Medical Technology Regulatory Affairs

Course Overview
About the programme
The programme is offered as a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits). The programme is delivered online using a combination of distance-learning / e-learning technologies and face to face workshops for an overall blended learning approach. The programme consists of 12 modules, each worth 5 ECTS. Three modules are delivered per semester. A dissertation (30ECTS) is also carried out over Year 1 and Year 2. Assessment of students is through continuous assessment

The MSc programme is also available for students to undertake in a modular format. Students undertaking the modular programme can select any individual module or combination of modules in any year, up to a maximum of three modules per semester. Students must complete all 12 taught modules and a research project within six years, to obtain an MSc degree. Postgraduate Certificate and Diplomas are also available as exit degrees, based on the completion of 6 or 12 taught modules.

Programme objectives are to:
- Produce graduates with the essential breadth and knowledge, skills and competencies required to work as a regulatory affairs professional in the Medical Technologies industry sector

- Provide participants with professional skills and knowledge to conduct appropriate advanced data analysis and interpretation in a highly regulated environment

- Enable participants to effectively communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public

- Provide participants with the skills and ability to function within, and adapt to, a changing medical technologies environment with rapidly evolving regulatory frameworks

- Prepare participants to provide strategic, tactical and operational direction and support to expedite the development and delivery of safe and effective healthcare products to the required regulatory standards

Course Outline
- The programme is offered as a two year, part-time, Level 9 MSc in Medical Technology Regulatory Affairs (90 credits)

- The MSc programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of three modules per semester

- The module programme offering gives students the option to complete all 12 taught modules and a research project within six years to obtain an MSc. degree

- Post-graduate Certificate and Diploma awards are also available, based on the completion of 6 or 12 taught modules

The programme is being made available online using a combination of distance-learning/e-learning technologies and some face-to- face workshops for an overall blended learning approach. The educational elements is provided by the Institute of Technology, Sligo, and University of Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.

The programme consists of 12 modules, each of 5 ECTS, delivered over 2 Years (6 modules per year), and a research Project (30 ECTS), carried out over both years of the programme.

Subjects taught

Year 1 (30 Credits)
Required MTR5101: EU Medical Device Regulatory Affairs - Introduction
Required MTR5102: US Medical Device Regulatory Affairs - Introduction
Required MTR5103: Technical Report Writing
Required MTR5104: Global Medical Technology Regulatory Affairs Part 1
Required MTR5105: Clinical Evaluation
Required MTR5106: Quality Management Systems

Year 2 (60 Credits)
Required MTR5107: EU Medical Technology Regulatory Affairs Advanced
Required MTR5108: US Medical Device Regulatory Affairs - Advanced
Required MTR5109: Risk Management, Labelling and Promotion
Required MTR5113: Medical Technology Regulatory Affairs DISSERTATION
Required MTR5110: Global Medical Technology Regulatory Affairs Part 2
Required MTR5111: Design Assurance, Sterilisation and Biocompatability
Required MTR5112: Post Market Surveillance

Entry requirements

Candidates must hold a least a Second Class Honours Level 8 primary degree in a related subject area in science or engineering and at least two years’ prior relevant experience in the medical technology industry. Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications. Applications from candidates who hold a relevant degree at Level 7, with at least two years’ medical technology industry experience in regulatory affairs, will also be considered.

Application dates

How to apply
We encourage all applicants to apply as early as possible.

Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specified closing date. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

Online Application
Applications to most postgraduate programmes at University of Galway are made online via www.universityofgalway.ie/apply (see "Application Weblink").

Duration

2 years, part-time distance learning (100% online).

Enrolment dates

Next start date: September 2024.

Review/Closing Dates (for Taught Programmes)
For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specifed closing date*. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

Post Course Info

Career Opportunities
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the global Medical Technology industry sector. It has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry and industry practitioners.

Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope. Operationally, a Regulatory Affairs professional is responsible for ensuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system. Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.

Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and are involved to some degree in bridging the gap between regulatory-related functions and organisation and business activities.

The Irish MedTech Association (IMA) asked senior MedTech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in MedTech organisations up to 2020. The IMA report (2017) has estimated that 4,000 additional Medical Technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in Quality roles. Over 30,000 people are employed in the highly successful and growing Irish Medical Technology industry sector, representing one of the leading global hubs of MedTech industries.

More details
  • Qualification letters

    MSc

  • Qualifications

    Degree - Masters (Level 9 NFQ)

  • Attendance type

    Part time

  • Apply to

    Course provider